Commercial Phase Clause Samples

Commercial Phase. (1) After successful completion of the Process Validation Campaign, Amylin shall use commercially reasonable efforts to have Sandoz approved by the FDA as manufacturer of the Product. Subject to such approval, Amylin has the right and obligation to exclusively purchase from Sandoz, and Sandoz shall Manufacture for Amylin, at least [***] of the entire Product demand of Amylin, its Affiliates and Amylin’s Product licensees, pursuant and subject to the terms and conditions of this Agreement. For purposes of satisfying the exclusivity provisions of this Clause 9(1) and subject to the Minimum Fee provisions set forth in Clause 9(3), Amylin shall have the option to purchase Product from Sandoz that has been manufactured in accordance with the terms and conditions of that certain Process Optimization and Manufacturing Agreement, dated June 25, 2010, between Amylin and Sandoz and any other Product manufacturing and/or supply agreement that may be entered into between the parties in writing. (2) For all Commercial Batches of Product ordered by Amylin, Amylin shall pay to Sandoz the purchase price set out in Schedule 7. Pricing model “A” on Schedule 7 shall apply for Firm Orders of [***] or more cGMP Batches per campaign. Pricing model “B” on Schedule 7 will apply for Firm Orders of [***] cGMP Batches per campaign. Notwithstanding the foregoing, if Amylin purchases Product under the terms of any other agreement as provided in Clause 9(1), Amylin shall pay the purchase price set out in such agreement. (3) [***]. (4) Sandoz covenants that: (a) It has and will maintain during the term of this Agreement, a manufacturer’s license. (b) It will perform the Services in accordance with this Agreement. It will Manufacture the Product in accordance with this Agreement, including utilizing the Process and (except for the Engineering Batches) in compliance with cGMP and the Specifications. With respect to Engineering Batches, Sandoz will use commercially, scientifically and technically reasonable efforts to achieve compliance of Engineering Batches with cGMP requirements and Product Specifications (including, for the avoidance of doubt, documentation required by cGMP and Sandoz quality systems), it being understood and agreed that (except for the aforesaid obligations to use commercially, scientifically and technically reasonable efforts) Sandoz shall have no obligation and/or liability whatsoever with respect to compliance of Engineering Batches with cGMP requirements and/or Pr...

Commercial Phase. Upon the Members' determination that the Company should proceed with commercial production of a Production Ready Prototype, the Company shall commence its second phase of operations (the "Commercial Phase") with respect to such Production Ready Prototype, and shall conduct all activities necessary or appropriate to manufacture and market fuel cell assemblies similar to such Production Ready Prototype, including the development, construction, ownership and operation of production facilities. (i) The President shall prepare and submit for Management Committee approval Annual Budgets for all subsequent Fiscal Years during the Commercial Phase in accordance with the Budget Protocol. Should the Company enter the Commercial Phase with respect to a Production Ready Prototype prior to completion of the R&D Phase with respect to other prototypes contemplated by the Development Program, the applicable Annual Budgets and Operating Plans shall separately identify Commercial Phase and R&D Phase costs and expenses. As more fully provided in Section 3.2, TESI and ECD shall be responsible for funding all costs and expenses incurred by the Company in the Commercial Phase and included in the applicable Approved Annual Budgets, to the extent such costs and expenses exceed cash available from the Company's operations or from third party funding obtained pursuant to Section 3.1(b). TESI shall fund the first $6 million in the aggregate necessary for Commercial Phase costs and expenses, and thereafter, TESI and ECD shall fund such costs and expenses in proportion to their respective Percentage Interests. (ii) The Members recognize that the market for the Company's products may outgrow the Company's ability to satisfy market demand with its existing manufacturing facilities. In this event, the Members may elect to cause the

Commercial Phase. Upon the Members' determination that the Company should proceed with commercial production of a Production Ready Prototype, the Company shall commence its second phase of operations (the "Commercial Phase") with respect to such Production Ready Prototype, and shall conduct all activities necessary or appropriate to manufacture and market hydrogen storage systems similar to such Production Ready Prototype, including the development, construction, ownership and operation of production facilities. (i) The President shall prepare and submit for Management Committee approval Annual Budgets for all subsequent Fiscal Years during the Commercial Phase in accordance with the Budget Protocol. Should the Company enter the Commercial Phase with respect to a Production Ready Prototype prior to completion of the R&D Phase with respect to other prototypes contemplated by the Development Program, the applicable Annual Budgets and Operating Plans shall separately identify Commercial Phase and R&D Phase costs and expenses.

Commercial Phase. Prior to commercialization of a product developed by the Alliance, the Parties will determine the appropriate mechanism for commercialization taking into consideration business, technical, legal, tax and financial matters with a guiding principle that the Parties will share equally in the value created by the Alliance through a joint venture corporation or partnership (the "Commercial Entity"). The Parties [...***...] that the Commercial Entity will be owned [...***...] by GCOR and [...***...] by DCC under the assumption that the Parties' [...***...]; provided, however, [...***...], the provisions of Section 8.3 hereof will govern. The decision by the Parties regarding whether to form the Commercial Entity will be triggered [...***...

Commercial Phase. 6.1 The price of the commercial batches of Material is specified on Exhibit C attached hereto and incorporated herein. 6.2 Celgene shall provide a firm written order for Material approximately three (3) months prior to the date of the anticipated FDA approval of Celgene's NDA and shall also provide to JMI a written forecast of its requirements for Material for the next succeeding nine (9) months. Every three (3) months thereafter for the term of the Agreement, Celgene shall provide JMI with a firm order for the next three (3) months and a revised nine (9) month forecast; JMI shall be entitled to rely upon the first three (3) months of such nine (9) month rolling forecast for purposes of obtaining the raw materials from its suppliers (other than Celgene) for Material. JMI agrees to process and deliver quantities ordered by Celgene within three (3) months of the date of receipt of Celgene's firm order; provided that Celgene shall supply, free of charge, Resolving Agent to JMI in sufficient quantities for JMI to fill such purchase order, at least four (4) months in advance of the anticipated delivery date for such ordered Material. Forecasts or firm orders shall be revised in writing by Celgene should the quantity of a forecast or firm order change exceed ten percent (10%) of Celgene's most recent projections. JMI shall use reasonable efforts to process and deliver quantities called for in the revised forecasts, and Article 11 hereof shall apply to production of such quantities. For example, if Celgene anticipates FDA approval in April of 2001, Celgene shall provide in December, 2000 a firm order for Material for April, May and June for 2001 and a forecast for Material requirements for July, 2001 through March, 2002. Celgene shall take delivery of such firm order Material for the firm order period. If the forecasted requirements change exceeds ten (10) percent of the forecasted quantities for any month between July, 2001 and March, 2002, a new forecast shall be provided to JMI. In March 2001, Celgene shall provide a firm order for Material for July through September, 2001 and a revised forecast for the months October, 2001 through June, 2002. Material for firm orders for this period shall agree within ten (10) percent of the previous forecast as provided for in this section. 6.3 Material shall be shipped FOB JMI's plant in such containers as may be agreed upon by the parties, packed in accordance with Department of Transportation and DEA requirements for inte...

Commercial Phase. Phase of Agreement starting on receipt by Customer of written notification from Life that Life has put in place a dedicated Product supply provision for Customer (“Life Notice of Commercial Supply”). *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Commercial Phase. HMN is to provide InnNovations with commercial grade content, for a minimum of 5000 rooms which in turn will be installed at all properties and then progress to a pay-per-view mode of operation. In this phase content will be restricted to new video releases only pending certification of the system by the MPAA (Motion Picture Association of America). HMN is to provide assistance to InnNovations in order to understand this process.

Commercial Phase. 3.1 The Commercial Phase for the CE-Approved Prototype shall commence upon the completion of the Prototype Development Phase and shall involve all duties and obligations as set forth in this Part 3. During the Commercial Phase, ATS shall undertake the tasks described in this Section 3; and the parties shall elaborate and agree on target launch dates for the U.S., major European markets, and other markets. 3.2 ATS shall be responsible for and shall bear all costs associated with obtaining the permits, licences, registrations, certificates, approvals and other regulatory authorisations required to manufacture, distribute, market, sell and use the CE-Approved Prototype, including without limitation, obtaining regulatory approvals in all non-CE countries and for any local work needed to transform the ▇▇-▇▇▇▇ into a marketing authorization in any other countries. ErySave will, on request, provide reasonable assistance to ATS and share with ATS any required information in ErySave's possession or control. 3.3 ErySave shall co-operate with ATS by providing data and information produced in the course of ErySave's development work on the Prototype as may assist ATS in obtaining the authorisations referred to in paragraph 3.2. ATS will, on request, share with ErySave all information in ATS' possession or control arising out of ATS activities in obtaining the authorizations referred to in paragraph 3.2 for use by ErySave with respect to any CE-Approved Product. 3.4 ErySave and ATS shall be jointly responsible for procuring the manufacturing of the Disposable Discs for the CE-Approved Prototype and for ensuring the supply of the Disposable Discs for the CE-Approved Prototype to ATS's contract manufacturer(s). 3.5 ATS shall be responsible for procuring the commercial manufacture and supply of remaining components of the CE-Approved Prototype and for assembly, sterilization and packaging of the final components of the CE-Approved Prototype; and ErySave shall assist ATS in the transfer and set-up of the processes and methods which will be required to manufacture the CE-Approved Prototypes by a commercial contract manufacturer or manufacturers agreed to in writing by both parties. 3.6 ATS shall use commercially reasonable efforts to diligently pursue the commercialization of the CE-Approved Prototypes and shall meet the requirements of the market by making or having made and offering or having offered for sale adequate quantities of the CE-Approved Prototypes on commercial...

Commercial Phase. Supply in the United States and Canada (i) During the Commercial Phase Nordion shall manufacture and supply Isotope to IDEC for use in Clinical Trials under IDEC's IND in the United States and IDEC's or its designee's IND or equivalents in Canada and Europe, and for commercial sale in Canada and the United States. IDEC shall, during the Commercial Phase, purchase from Nordion [CONFIDENTIAL TREATMENT REQUESTED]. Except as otherwise set out in this agreement, during the Commercial Phase IDEC agrees that it shall not, [CONFIDENTIAL TREATMENT REQUESTED].